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The blood test can detect a biomarker for NETosis, can predict disease severity and can monitor its progression and the response to treatment, the company said. Read More
Carthera, a French medtech company that makes ultrasound-based medical devices to treat brain disorders, has earned the FDA’s Breakthrough Device designation for its SonoCloud-9 system. Read More
The antimicrobial susceptibility testing device received a Breakthrough Device designation from the FDA earlier this year, but it has not yet received the agency’s 510(k) clearance. Read More